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Regulatory Compliance Specialist

hace 2 semanas

Cartagena, Murcia, España beBeeRegulatory A tiempo completo
Regulatory Affairs Manager

We are seeking a highly skilled Regulatory Affairs Manager to join our team. The ideal candidate will have extensive experience in regulatory affairs, with a proven track record of developing and executing effective regulatory strategies.

This is a challenging role that requires strong organizational and communication skills, as well as the ability to manage multiple projects simultaneously. The successful candidate will be responsible for ensuring compliance with regulatory requirements and providing expert guidance on regulatory matters.

  • Developing and executing a regulatory strategy to support the registration of products in line with applicable regulatory requirements.
  • Preparing, developing and analyzing CMC documentation for Module 3, quality summaries and safety and efficacy documentation.
  • Working on safety, efficacy and CMC variations: variation typification and documentation preparation.
  • Supporting R&D, manufacturing, quality control and quality assurance departments for potential queries.
  • Submitting regulatory documentation to authorities ensuring compliance with the regulatory standards.
  • Planning and managing regulatory procedures on behalf of client companies.
  • Ensuring ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
Required Skills and Qualifications
  • Bachelors or masters degree in health science.
  • 7+ years in regulatory affairs, with at least 3 years of experience in pharmaceutical company.
  • Familiarity with European e-submission portals.
  • Practical experience working with different National Competent Authorities (NCAs).
  • Experience of small and large molecules, ideally across multiple therapy areas/dosage forms.
  • Working experience in writing and reviewing module 3, module 4 and module 5.
Benefits
  • Permanent contract.
  • Competitive salaries.
  • Benefits package (medical insurance, disability insurance, pension plan and flexible remuneration).
  • Flexible working schedule.
  • Wide variety of projects, new challenges and experiences.